Androgenic Anabolic Steroids Monograph

Written information about this prescription has been provided for you. Please read this information before you take the medication. If you have questions concerning this prescription, a pharmacist is available during normal business hours to answer these questions at 888-689-2271

Información por escrito acerca de esta receta se le a presentado a usted. Favor de leer esta información antes de tomar el medicamento. Si usted tiene preguntas tocante esta receta, un farmacéutico estará presente durante horas de negocio para contestar sus preguntas

Complaints concerning the practice of pharmacy may be filed with the Texas State Board of Pharmacy at:

Quejas sobre la practica de farmacia pueden ser reportadas al Concilio Farmacia del Estado de Tejas:

William P. Hobby Building Ste. 3-600, 333 Guadalupe Street, Box 21

Austin, Texas 78701-3942 Tel: (512) 305-8000 www.tsbp.state.tx.us

 

Oxandrolone is an androgenic anabolic steroid previously sold under the brand names Oxandrin and Anavar

Nandrolone is an androgenic anabolic steroid previously sold under the brand name Deca-Durabolin

Oxymetholone is an androgenic anabolic steroid previously sold under the brand name Anadrol

Stanozolol is an androgenic anabolic steroid previously sold under the brand name Winstrol

All androgenic anabolic steroids are controlled substance because they can be used to improve physique and athletic performance

Renal Dosing: There are no dosage adjustments provided in the manufacturer’s labeling; use with caution due to propensity to cause edema

Hepatic Impairment:

Preexisting impairment: There are no dosage adjustments provided in the manufacturer’s labeling; use with caution

Hepatotoxicity during therapy: discontinue use if abnormal liver function tests or cholestatic hepatitis with jaundice occurs

Contraindications: Nephrosis; breast cancer in females with hypercalcemia; known or suspected prostate or breast cancer in males; hypercalcemia; pregnancy

Warnings/Precautions:

Blood lipid changes: [US Boxed Warning]: May cause blood lipid changes with increased risk of arteriosclerosis. Use caution in patients at risk for, or with a history of cardiovascular disease; monitor lipid profile and adjust therapy as indicated. Lipid changes are usually reversible upon discontinuation of therapy

Gynecomastia: May cause gynecomastia

Hepatic effects: [US Boxed Warning]: Anabolic steroids may cause peliosis hepatis or liver cell tumors which may not be apparent until liver failure or intra-abdominal hemorrhage develops. Discontinue in case of cholestatic hepatitis with jaundice or abnormal liver function tests; drug-induced jaundice is reversible upon discontinuation. Use with caution in patients with hepatic impairment

Oligospermia: May suppress spermatogenesis; oligospermia may occur

Polycythemia: Increased hemoglobin and hematocrit may occur with high doses of anabolic steroids; monitor

Priapism: Priapism or excessive sexual stimulation may occur

Carbohydrate intolerance: May have adverse effects on glucose tolerance; use caution in patients with diabetes

Edematous conditions: Use with caution in patients with conditions influenced by edema (eg, cardiovascular disease, migraine, seizure disorder, hepatic impairment, renal impairment); may cause fluid retention

Drug Interactions:significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information

Adverse Reactions: Edema, deepening of the voice (females), depression, excitement, habituation, insomnia, acne vulgaris, androgenetic alopecia (females), changes in libido, decreased glucose tolerance, decreased HDL cholesterol, electrolyte disturbance, gynecomastia, hirsutism (females), increased LDL cholesterol, inhibition of gonadotropin secretion, menstrual disease (females), clitoromegaly (females), epididymitis (postpubertal males), erectile dysfunction (prepubertal males; increased or persistent erections), impotence (postpubertal males), inhibition of testicular function (postpubertal males), irritable bladder (postpubertal males), oligospermia (postpubertal males), phallic enlargement (prepubertal males), priapism (chronic; postpubertal males), testicular atrophy (postpubertal males), clotting factors suppression, prolonged prothrombin time, cholestatic jaundice, hepatocellular neoplasm, increased serum alkaline phosphatase, increased serum ALT, increased serum AST, increased serum bilirubin, peliosis hepatitis (long-term therapy), increased creatine phosphokinase, increased creatinine clearance

Storage: Room temperature

Patient Education:

What should I tell my doctor about before taking this medication?

If you have an allergy to any other part of this drug; if you have any of these health problems: Breast cancer, high calcium levels, kidney disease, or prostate cancer; if you are pregnant or may be pregnant; if you are breast-feeding or plan to breast-feed; if you have high blood sugar (diabetes)

Have blood work checked as you have been told by the doctor. Talk with your doctor

This drug is an anabolic steroid. Anabolic steroid drugs have been abused and misused before. Anabolic steroid abuse can lead to dependence and very bad health problems. These health problems include heart or blood vessel problems, stroke, liver problems, and mental or mood problems. Talk with your doctor

What side effects should I call my doctor about right away?

Liver and spleen problems have happened with drugs like this one. Sometimes, these have been very bad or deadly. Signs may not happen until these problems become very bad. Call your doctor right away if you see signs of liver or spleen problems like dark urine, feel tired, are not hungry, have an upset stomach or stomach pain, are throwing up, or have yellowing of the skin or eyes

Cholesterol levels may change with the use of drugs like this one. This may raise the chance of heart disease

Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat; signs of high calcium levels like weakness, confusion, feeling tired, headache, upset stomach and throwing up, constipation, or bone pain; very nervous and excitable; any unexplained bruising or bleeding; shortness of breath, a big weight gain, or swelling in the arms or legs; low mood (depression); bladder irritation; enlarged breasts; for males, erections that happen often or that last a long time; change in size or shape of testicles; for females, a deep voice, facial hair, pimples, or period changes